loteprednol etabonate and tobramycin

Generic: loteprednol etabonate and tobramycin

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loteprednol etabonate and tobramycin
Generic Name loteprednol etabonate and tobramycin
Labeler alembic pharmaceuticals limited
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

loteprednol etabonate 5 mg/mL, tobramycin 3 mg/mL

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-801
Product ID 46708-801_a6d68829-f7b6-4b9b-ad44-110c47609918
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217597
Listing Expiration 2026-12-31
Marketing Start 2025-12-10

Pharmacologic Class

Established (EPC)
aminoglycoside antibacterial [epc]
Chemical Structure
aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708801
Hyphenated Format 46708-801

Supplemental Identifiers

RxCUI
545255
UNII
YEH1EZ96K6 VZ8RRZ51VK
NUI
N0000175477 M0000946

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name loteprednol etabonate and tobramycin (source: ndc)
Generic Name loteprednol etabonate and tobramycin (source: ndc)
Application Number ANDA217597 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (46708-801-05) / 5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (46708-801-10) / 10 mL in 1 BOTTLE
source: ndc

Packages (2)

46708-801-05 1 BOTTLE in 1 CARTON (46708-801-05) / 5 mL in 1 BOTTLE 46708-801-10 1 BOTTLE in 1 CARTON (46708-801-10) / 10 mL in 1 BOTTLE

Ingredients (2)

loteprednol etabonate (5 mg/mL) tobramycin (3 mg/mL)

Linked Drug Pages (1)

Loteprednol etabonate and Tobramycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "a6d68829-f7b6-4b9b-ad44-110c47609918", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["YEH1EZ96K6", "VZ8RRZ51VK"], "rxcui": ["545255"], "spl_set_id": ["a6d68829-f7b6-4b9b-ad44-110c47609918"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (46708-801-05)  / 5 mL in 1 BOTTLE", "package_ndc": "46708-801-05", "marketing_start_date": "20251210"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (46708-801-10)  / 10 mL in 1 BOTTLE", "package_ndc": "46708-801-10", "marketing_start_date": "20251210"}], "brand_name": "Loteprednol etabonate and Tobramycin", "product_id": "46708-801_a6d68829-f7b6-4b9b-ad44-110c47609918", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "46708-801", "generic_name": "Loteprednol etabonate and Tobramycin", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loteprednol etabonate and Tobramycin", "active_ingredients": [{"name": "LOTEPREDNOL ETABONATE", "strength": "5 mg/mL"}, {"name": "TOBRAMYCIN", "strength": "3 mg/mL"}], "application_number": "ANDA217597", "marketing_category": "ANDA", "marketing_start_date": "20251210", "listing_expiration_date": "20261231"}